Marberger 1998.

Methods	A multi center, randomized, double‐blind, placebo‐controlled trial for men with moderate symptomatic BPH.
Participants	Geographic region: Multinational Study setting: NA N = 2902 in the efficacy analysis (finasteride n = 1450; placebo n = 1452) (enrolled = 3270 men) Baseline modified Boyarsky (Boyarsky I) (range 0 to 54): finasteride = 14.5 points; placebo = 14.3 points Baseline peak urine flow: finasteride = 11.2 mL/s; placebo = 10.9 mL/s Baseline prostate volume: finasteride = 38.7 cc; placebo = 39.2 cc Baseline PSA: NA Mean age (range): 63.2 years (50 to 75) Race: NA Inclusion: diagnosis of BPH; age of 50 to 75 years and in good general health; maximal urinary flow rate of 5 to 15 mL/s with a voided volume of 150 mL or more, documented by two measurements, both at screening and month 21 visits; at least two urinary symptoms indicating moderate BPH, but not more than two severe symptoms, based on a modified Boyarsky scale; enlarged prostate gland detected by DRE; PSA level < 10 ng/mL; post void residual urine volume < 150 mL Exclusion: a history of any illness that might confound the results of the study or confer additional risk; dysuria, hematuria, or UTI (a thorough examination, including urine cytology, rule out active urinary tract infection, prostatitis, or urinary bladder carcinoma); abnormalities on clinical examination or in laboratory tests; liver function tests 50% above the ULN; multiple and/or severe allergies; treatment with any other investigational drug during the previous 3 months, or chronic/concurrent use of antiandrogenic drugs, alpha‐blockers, clonidine, or plant extracts; history of drug or alcohol abuse; history of predisposing conditions to urethral strictures; definitive diagnosis of chronic bacterial prostatitis; (10) previous prostatectomy or other invasive surgical procedures for the treatment of BPH; evidence or suggestion of prostate cancer; a history suggestive of neurogenic bladder; urinary catheterization for acute urinary retention (AUR) at least twice during the last 2 years; poor compliance (less than 80%) with placebo during the run‐in phase; planned fatherhood Study discontinuations: n = 691 (finasteride n = 331 (22.8%); placebo n = 360 (24.8%)) Study duration: 2 years (plus a 1‐month, placebo run‐in)
Interventions	Finasteride 5 mg once daily Placebo
Outcomes	Modified Boyarsky (Boyarsky I) (range 0 to 54) Peak urine flow Prostate volume BPH progression (acute urinary retention) BPH progression (need for surgical intervention)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	computer‐generated allocation schedule
Allocation concealment (selection bias)	Low risk	"Patients and investigators were unaware of treatment allocation"
Blinding (performance bias and detection bias) All outcomes	Low risk	"Placebo and finasteride tablets were identical in appearance and taste." This was probably a single blind, double‐dummy design.
Incomplete outcome data (attrition bias) All outcomes	Low risk	yes
Selective reporting (reporting bias)	Low risk	yes
Other bias	Low risk	yes
Intention‐to‐treat analysis	Low risk	yes
Non‐industry funded	High risk	funded by Merck Research Labs